FDA Labels API
Retrieve FDA drug label (package insert) content.
Overview
The FDA Labels API provides access to structured drug label content from FDA DailyMed. Labels include prescribing information, warnings, dosing instructions, and more.
Endpoints
| Method | Path | Description |
|---|---|---|
| GET | /v1/fda-label/:identifier | Get label by NDC, RxCUI, or Set ID |
| GET | /v1/fda-label/:identifier/sections/:bundle | Get specific section bundle |
| POST | /v1/fda-label/_batch | Batch lookup (up to 50) |
| GET | /v1/fda-label/sections-info | List available sections and bundles |
Lookup by Identifier
You can look up labels using:
- NDC:
0069-0151-01 - RxCUI:
197361 - Set ID:
a1b2c3d4-e5f6-...(UUID)
Look up Lipitor label by NDC
Request
Node.js
import { Fhirfly } from "@fhirfly-io/terminology";
const client = new Fhirfly({ apiKey: "YOUR_API_KEY" });
const result = await client.fdaLabels.lookup("0069-0151-01");
console.log(result.data);Response
JSON
{
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"version": "15",
"effective_date": "2023-06-15",
"product_name": "Lipitor",
"sections": {
"indications_and_usage": {
"title": "INDICATIONS AND USAGE",
"text": "..."
},
"dosage_and_administration": {
"title": "DOSAGE AND ADMINISTRATION",
"text": "..."
}
}
},
"meta": {
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}Section Bundles
Request specific sections using the bundle parameter:
| Bundle | Sections Included |
|---|---|
safety | Warnings, contraindications, adverse reactions |
dosing | Dosage, administration, how supplied |
interactions | Drug interactions, clinical pharmacology |
pregnancy | Pregnancy, lactation, pediatric/geriatric use |
ingredients | Active/inactive ingredients, description |
Get safety-related sections
Request
Node.js
const response = await fetch(
"https://api.fhirfly.io/v1/fda-label/0069-0151-01?bundle=safety",
{
method: "GET",
headers: {
"x-api-key": "YOUR_API_KEY",
}
}
);
const data = await response.json();
console.log(data);Response
JSON
{
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"version": "15",
"effective_date": "2023-06-15",
"product_name": "Lipitor",
"sections": {
"warnings_and_precautions": {
"title": "WARNINGS AND PRECAUTIONS",
"text": "..."
},
"contraindications": {
"title": "CONTRAINDICATIONS",
"text": "..."
}
}
},
"meta": {
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}Individual Sections
Request specific sections with the sections parameter:
Get specific sections
Request
Node.js
const response = await fetch(
"https://api.fhirfly.io/v1/fda-label/0069-0151-01?sections=boxed_warning,contraindications",
{
method: "GET",
headers: {
"x-api-key": "YOUR_API_KEY",
}
}
);
const data = await response.json();
console.log(data);Response
JSON
{
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"product_name": "Lipitor",
"sections": {
"boxed_warning": {
"title": "BOXED WARNING",
"text": "..."
},
"contraindications": {
"title": "CONTRAINDICATIONS",
"text": "..."
}
}
},
"meta": {
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}Metadata Only
Get label metadata without section content:
Get metadata only
Request
Node.js
const response = await fetch(
"https://api.fhirfly.io/v1/fda-label/0069-0151-01?meta=true",
{
method: "GET",
headers: {
"x-api-key": "YOUR_API_KEY",
}
}
);
const data = await response.json();
console.log(data);Response
JSON
{
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"version": "15",
"effective_date": "2023-06-15",
"product_name": "Lipitor"
},
"meta": {
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}Batch Lookup
Look up multiple labels in a single request (up to 50):
Look up multiple drug labels
Request
Node.js
import { Fhirfly } from "@fhirfly-io/terminology";
const client = new Fhirfly({ apiKey: "YOUR_API_KEY" });
const result = await client.fdaLabels.lookupMany(["0069-0151-01","0003-0893-01","0054-0018-25"]);
console.log(result.data.results);Response
JSON
{
"count": 3,
"results": [
{
"input": "0069-0151-01",
"status": "ok",
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"product_name": "Lipitor"
}
},
{
"input": "0003-0893-01",
"status": "ok",
"data": {
"set_id": "b2345678-c901-d234-e567-f89012345678",
"product_name": "Norvasc"
}
},
{
"input": "0054-0018-25",
"status": "ok",
"data": {
"set_id": "c3456789-d012-e345-f678-901234567890",
"product_name": "Metformin Hydrochloride"
}
}
],
"meta": {
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}Batch with shape=full
When using shape=full on batch requests, the response includes meta.source with provenance information:
POST /v1/fda-label/_batch?shape=full
{
"count": 3,
"results": [
{
"input": "0069-0151-01",
"status": "ok",
"data": {
"set_id": "a1234567-b890-c123-d456-e78901234567",
"product_name": "Lipitor"
}
}
],
"meta": {
"source": {
"name": "FDA DailyMed",
"url": "https://dailymed.nlm.nih.gov/dailymed/",
"version": "weekly",
"fhirfly_updated_at": "2026-03-01T03:00:00Z"
},
"legal": {
"license": "public_domain",
"citation": "FDA DailyMed"
}
}
}
Required Scope
fda-label.read- Single and batch lookups
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